CSA Z15883-2:09 (R2019):2009 Edition

CSA Preface

This is the first edition of CAN/CSA-Z15883-2, Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc., which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-2 (first edition, 2006-04-15).

This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.

Scope

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.

NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two.

The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1.

The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

NOTE 2 If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation.